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Nov 22, 2011

FDA Clears Abbott’s Confirmatory Chagas Disease Assay

  • FDA approved Abbott’s in vitro enzyme strip assay for Chagas disease. The Abbott ESA Chagas test detects antibodies to the causative pathogen Trypanosoma cruzi in serum or plasma samples. It is indicated for use as an additional, more specific test on human samples that have been found to be repeatedly reactive using a licensed screening test.

    The T. cruzi parasite is transmitted through contact with the feces of an infected triatomine bug, but infection can also occur congenitally, through transfusions of contaminated blood products, or through an organ transplant from an infected donor.

    U.S. Centers for Disease Control and Prevention (CDC) estimates suggest that as many as 11 million people worldwide are infected with Chagas disease, including over 300,000 in the U.S. alone. Concerns about Chagas disease transmission through blood led FDA to implement mandatory Chagas disease screening of donated blood back in 2007. “The new Abbott ESA Chagas test provides organizations that screen blood with an approved testing method help the blood supply safe and enable them to confidently counsel infected donors,” remarks John Coulter, divisional vp for Abbott’s diagnostics business. 

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